Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208687
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription AB No No
AZATHIOPRINE AZATHIOPRINE 100MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/27/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

AZATHIOPRINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 208687 ALKEM LABS LTD
AZATHIOPRINE AZATHIOPRINE 25MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 208687 ALKEM LABS LTD
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 074069 AMNEAL
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 075568 RISING
AZATHIOPRINE AZATHIOPRINE 50MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA
IMURAN AZATHIOPRINE 50MG TABLET;ORAL Prescription Yes AB 016324 SEBELA IRELAND LTD

TABLET;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 208687 ALKEM LABS LTD
AZATHIOPRINE AZATHIOPRINE 75MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZASAN AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 075252 AAIPHARMA LLC
AZATHIOPRINE AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 208687 ALKEM LABS LTD
AZATHIOPRINE AZATHIOPRINE 100MG TABLET;ORAL Prescription No AB 077621 ZYDUS PHARMS USA

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